Medical Director, Oncology Clinical Development (Solid Tumors)
About The Position
With supervision, the Medical Director oversees the direction, planning, execution, and interpretation of clinical trials or research activities for a clinical development program. The role participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data that supports product scientific and business strategy. The position manages study protocol design and implementation with appropriate supervision, based on medical and scientific principles and knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. It oversees study integrity, reviews and communicates accumulating safety and efficacy data, and works with Clinical Operations on enrollment and key deliverable timelines. The Medical Director also assesses and reports serious adverse events in accordance with corporate policy and regulations for assigned protocols. The role contributes to scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. It may represent the clinical function on a Clinical Strategy Team and contributes to a cross-functionally aligned Clinical Development Plan. The position also participates in opinion-leader interactions, keeps current with developments in the therapeutic area, understands and complies with regulatory requirements, and ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.
Requirements
- M.D., D.O., or non-U.S. equivalent M.D. degree with a relevant therapeutic specialty in an academic or hospital environment.
- Ability to run a clinical research study with appropriate supervision.
- Strong desire to collaborate in a cross-functional setting.
- Ability to interact externally and internally to support global scientific and business strategy.
- Excellent oral and written English communication skills.
Nice To Haves
- Completion of a residency program is strongly preferred.
- Completion of a subspecialty fellowship is desirable.
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
- Knowledge of clinical trial methodology and regulatory and compliance requirements governing clinical trials, and experience designing study protocols, is desirable.
Responsibilities
- Manage the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, with appropriate supervision.
- Oversee project-related education for investigators, study site personnel, and AbbVie study staff.
- Oversee clinical studies, monitor study integrity, and review, interpret, and communicate accumulating safety and efficacy data.
- Work with Clinical Operations to oversee study enrollment and timelines for key deliverables.
- Assess and report serious adverse events according to corporate policy and regulations for assigned protocols.
- Contribute to the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- May serve on a Clinical Strategy Team as the clinical representative for assigned protocols.
- Contribute to development of a rigorous, cross-functionally aligned Clinical Development Plan with matrix team members.
- Participate in opinion-leader interactions related to disease areas, partnering with Medical Affairs, Commercial, and other functions as required and consistent with corporate policies.
- Stay abreast of professional information and technology through conferences, medical literature, and other training.
- Understand regulatory requirements for clinical studies and global drug development, comply with them, and potentially contribute to regulatory responses and discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
